**Job Description:**
We are seeking a highly experienced and skilled laboratory management specialist to join our team. The successful candidate will be responsible for overseeing laboratory activities, managing the microbiology team, and ensuring compliance with regulatory requirements.
Responsibilities:
* Technical leadership: provide expert advice, guidance, and support on microbiological issues.
* Team management: manage the microbiology laboratory team, including recruitment, training, and employee development.
* Testing and validation: responsible for managing the microbiology testing program, ensuring all testing methods and validation exercises reflect applicable regulations/guidelines and meet industry best practice.
* KPI management: accountable for meeting targeted KPIs and monitoring team performance; maintain and update all assigned systems and databases.
* Reporting: provides regular management reports as required.
Requirements:
* 7+ years' experience in the Medical Device/Pharmaceutical Industry within a R&D/product development role.
* Experience with FDA 510k submissions and test methods for microbiological claims.
* Strong background in microbiology, significant experience, track record, and knowledge within Microbiology or a Laboratory Management environment.
* Drive for excellence and high attention to detail.
* Leadership and team management skills.
Education and Qualifications:
* Degree level in a biological science discipline, preferably in microbiology.
* Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2015) and GMP Guidelines and Regulations.